Nitrazepam Gsk

Package Leaflet: Information for the Patient

NITRAZEPAM GSK, 5 mg, tablets

Nitrazepam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What Nitrazepam GSK is and what it is used for
• 2. Important information before taking Nitrazepam GSK
• 3. How to take Nitrazepam GSK
• 4. Possible side effects
• 5. How to store Nitrazepam GSK
• 6. Contents of the pack and other information

1. What Nitrazepam GSK is and what it is used for

Nitrazepam GSK belongs to a group of medicines called benzodiazepines. The active substance is nitrazepam. The medicine has a sedative, calming, and anticonvulsant effect. It also reduces muscle tension.

Indications for Use

Short-term treatment of severe insomnia characterized by difficulty falling asleep and frequent nocturnal awakenings, taking into account that the patient may experience excessive sedation and daytime sleepiness when taking this medicine.

2. Important information before taking Nitrazepam GSK

When not to take Nitrazepam GSK

• If you are allergic to the active substance, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6);
• If you have myasthenia gravis (a disease characterized by muscle weakness);
• If you have severe respiratory failure, respiratory depression;
• If you have sleep apnea syndrome (repeated pauses in breathing during sleep, leading to hypoxia);
• If you have severe liver failure;
• If you have phobias, obsessions, or chronic psychosis;
• Nitrazepam GSK should not be used for short-term treatment of insomnia in children and adolescents;
• Nitrazepam GSK should not be used in children.

Warnings and Precautions

• In rare cases, sensitive patients may experience hypersensitivity reactions, including rash, angioedema, and increased blood pressure (hypertension).
• If you have a history of alcohol or drug abuse, were dependent, and are taking other benzodiazepines or have personality disorders, Nitrazepam GSK should be used with special caution (see section: Nitrazepam GSK and other medicines).
• Long-term use of Nitrazepam GSK may lead to psychological and physical dependence (see section 4: Possible side effects).
• After sudden discontinuation of the medicine (even in patients taking therapeutic doses for a short time), withdrawal symptoms may occur, such as depression, headaches, muscle weakness, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, recurring insomnia, irritability, sweating, and diarrhea.
• If Nitrazepam GSK is used for several weeks, a decrease in the efficacy of the sedative effect may occur.
• In the case of benzodiazepines with a long duration of action, switching to short-acting drugs may cause withdrawal symptoms. In severe cases, the following symptoms may occur: loss of reality, personality disorders, hypersensitivity to sound, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, or seizures. In rare cases, withdrawal from the medicine after taking higher than recommended doses may cause confusion, psychotic symptoms, and seizures (see section 4).
• When discontinuing the medicine, withdrawal symptoms or rebound phenomenon may occur, i.e., a transient phenomenon in which the symptoms that led to the treatment with benzodiazepines or similar-acting substances return in an intensified form. This may be accompanied by other symptoms, such as mood changes, anxiety, and restlessness. This phenomenon is related to the sudden discontinuation of the medicine, so it is recommended to gradually reduce the dose.
• During treatment, unusual psychological reactions may occur. These symptoms can be severe. Rarely, they include: paradoxical outbursts of aggression, excitement, confusion, restlessness, irritability, delusions (false beliefs), anger, nightmares, hallucinations, psychosis, behavioral disorders, and the emergence of depression with suicidal tendencies. The risk of these reactions is higher in the elderly (over 65 years). If any of these symptoms occur, the medicine should be discontinued.
• In the event of loss or bereavement, benzodiazepines may hinder psychological adaptation. Taking Nitrazepam GSK in people who are bereaved (e.g., after the loss of loved ones) does not improve well-being. Nitrazepam GSK may cause anterograde amnesia (inability to learn and remember new information), which usually occurs 1 to 2 hours after taking the medicine and may last for several hours (see section 4. Possible side effects).
• If you have depression or anxiety associated with depression, Nitrazepam GSK should not be used as the only medicine, as it may increase the risk of suicide.
• If you have chronic pulmonary insufficiency, chronic kidney or liver disease, a lower dose of the medicine should be used.
• The medicine reduces muscle tension. This can lead to falls and fractures, especially in elderly patients.
• During the action of this medicine, memory disorders may occur.
• Benzodiazepines are not recommended for the treatment of primary phobias or obsessive states, chronic psychoses, or psychotic disorders.

Nitrazepam GSK and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Nitrazepam GSK enhances the effectof medicines such as:

• antipsychotic medicines,
• sedatives,
• medicines used to treat depression,
• sleeping medicines,
• medicines used to treat epilepsy (e.g., hydantoin or barbiturates). Special caution should be exercised when setting the dosage in the initial stage of treatment,
• anxiolytic (anti-anxiety) medicines,
• analgesic, opioid analgesics, causing an increase in the euphoric effect (excessive joy), which can lead to increased psychological dependence. Elderly patients require special supervision. Concomitant use of Nitrazepam GSK and opioids (strong painkillers, medicines used for substitution therapy of addictions, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment methods are not possible. If, however, the doctor has prescribed Nitrazepam GSK together with opioids, the dose and duration of combined treatment should be limited. You should inform your doctor about all opioid medicines you are taking and strictly follow their instructions. It may be helpful to inform friends or family members to be aware of the above symptoms. If such symptoms occur, you should contact your doctor.
• anesthetics,
• antihistamines with a sedative effect (used to treat, e.g., allergies),
• medicines used to treat hypertension and beta-blockers.

Medicines that weaken the action of liver enzymes, such as cimetidine, some antifungal medicines from the azole group, omeprazole, antiretroviral protease inhibitors, macrolide antibiotics, calcium channel blockers, selective serotonin reuptake inhibitors (SSRIs), and disulfiram, may enhance the effect of Nitrazepam GSK. Medicines that increase the action of liver enzymes (e.g., the antibiotic rifampicin or St. John's Wort) may weaken the effect of Nitrazepam GSK. Concomitant administration of theophylline or aminophylline may weaken the sedative effect of benzodiazepines. Concomitant administration of benzodiazepines and sodium oxybate may enhance the effect of sodium oxybate. Concomitant administration of valerian may enhance or weaken the effect of nitrazepam.

If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.

Nitrazepam GSK and alcohol

Do not drink any alcoholic beverages while taking this medicine. Alcohol enhances the sedative effect of Nitrazepam GSK.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. It is not recommended to use the medicine in pregnant women, especially in the first and third trimester of pregnancy. Taking Nitrazepam GSK during pregnancy or breastfeeding is only allowed when the doctor considers it absolutely necessary. In newborns born to mothers who have been taking benzodiazepines for a long time during the last period of pregnancy, physical dependence may occur, with the development of withdrawal symptoms in the postpartum period. Benzodiazepines used in the last three months of pregnancy or during childbirth may cause fetal heart rate disturbances and reduced muscle tone, difficulties in sucking, hypothermia (body temperature below 36°C), and respiratory disorders in the newborn. The medicine passes into breast milk, so it should not be used during breastfeeding.

Driving and using machines

Nitrazepam GSK may cause impaired psycho-physical fitness and affect the ability to drive vehicles. Like all medicines of this type, nitrazepam may affect the ability to perform tasks that require skill. Sedation, amnesia, concentration disorders, and muscle function disorders can adversely affect the ability to drive vehicles and operate machines. The likelihood of attention disorders may increase if the patient's sleep time is not long enough. Do not drive vehicles until the effect of the medicinal product on the patient has been established. Check the current local traffic regulations.

The medicine contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Nitrazepam GSK

Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor. If you are not sure, ask your doctor or pharmacist. The medicine should be taken orally. The duration of treatment should not exceed 4 weeks. The recommended dose is:

Adults

1 to 2 tablets (5 mg to 10 mg) before bedtime.

Patients over 65 years of age

Initially, half a tablet (2.5 mg) before bedtime. If necessary, the doctor may recommend increasing the dose to 5 mg (1 tablet).

Use in children and adolescents

Do not use this medicine in children and adolescents.

Taking a higher dose of Nitrazepam GSK than recommended

If you have taken a higher dose of the medicine than recommended, seek medical attention immediately. Have the carton of the medicine with you to show the doctor. Depending on the dose taken, the following overdose symptomsmay occur:

• drowsiness, confusion, slurred speech (swallowing sounds), lethargy;
• ataxia (coordination disorders), reduced muscle tone, decreased blood pressure (hypotension), breathing difficulties, shortness of breath, respiratory depression, coma, and even death.

After an overdose of benzodiazepines taken orally, if the patient is conscious, induce vomiting (within one hour of taking the product). If gastric emptying does not bring benefits, administer activated charcoal to reduce absorption. The medicine can be given within 1 hour of taking a significant amount of the product, provided the patient is conscious and their airways are clear. Respiratory and cardiac function should be monitored in the intensive care unit. The antidote in the treatment of overdose is flumazenil.

Missing a dose of Nitrazepam GSK

If you miss a dose, take the medicine as soon as possible. If it is almost time for the next dose, skip the missed dose. Take the next dose as directed by your doctor. Do not take a double dose of the medicine to make up for the missed dose.

Stopping Nitrazepam GSK

The medicine should be discontinued gradually, strictly according to the doctor's instructions. Sudden discontinuation of Nitrazepam GSK may cause withdrawal symptoms, such as: depression, headaches, muscle weakness, nervousness, extreme anxiety, tension, restlessness, confusion, mood changes, recurring insomnia, irritability, sweating, and diarrhea. If you have any doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nitrazepam GSK can cause side effects, although not everybody gets them. You should immediately contact your doctor if you experience any of the following serious side effects, as they may require immediate medical attention:

• Allergic reactions (hypersensitivity) - swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
• Rash or other skin allergic reactions, red skin, or itching, pale skin covered with red irregular spots with severe itching (hives), irregular ring-shaped spots on the skin of the hands and arms (erythema multiforme), severe skin rash with redness, fever, blisters, or ulcers, sore throat, fatigue (Stevens-Johnson syndrome).

During treatment, changes in behavior may occur. If they do, you should contact your doctor. The doctor may decide to discontinue the medicine. Changes in behavior may include: aggression, excitement, confusion, restlessness, irritability, anger, delusions, nightmares, hallucinations, psychosis. Common side effects(may occur in less than 1 in 10 patients):

• emotional inhibition;
• headache;
• fatigue;
• confusion (disorders of consciousness, thought disorders, orientation disorders regarding time, place, situation, or own person);
• depression; During benzodiazepine treatment, previously existing depression may be revealed.
• muscle weakness.

Rare side effects(may occur in less than 1 in 1000 patients):

• decreased or increased sexual desire (libido);
• dyzartria (speech disorder);
• vertigo of vestibular origin (feeling of spinning or movement of the environment);
• discomfort in the abdominal cavity and nausea;
• skin rashes.

Side effects with unknown frequency(frequency cannot be estimated from the available data)
:

• changes in blood count;
• skin allergic reaction, anaphylactic reaction, angioedema;
• emotional numbness (the patient does not express emotions that they experience);
• emotional disorders;
• delirium;
• reduced concentration ability;
• insomnia;
• cognitive function disorders;
• physical and psychological dependence;
• withdrawal syndrome, which is accompanied by symptoms including mood changes, anxiety, and restlessness, drug abuse, excitement, aggression, delusions, anger, nightmares, hallucinations, psychotic disorders;
• inability to learn and remember new information (so-called anterograde amnesia); to prevent it, the patient should have uninterrupted 7-8 hours of sleep; it may be accompanied by behavioral disorders;
• feeling of drowsiness during the day;
• dizziness, disorientation, impaired motor coordination (ataxia);
• balance disorders, hypokinesia, tremors, seizures;
• respiratory depression, increased tracheal secretions;
• double vision, vision disorders;
• dizziness;
• decreased blood pressure;
• gastrointestinal disorders (e.g., bloating);
• jaundice (yellowing of the skin and whites of the eyes);
• hives, itching, skin inflammation, erythema multiforme, Stevens-Johnson syndrome;
• muscle cramps;
• inability to urinate (strong urge to urinate, pain in the lower abdomen);
• irritability;
• rebound effect, occurring after discontinuation of the medicine or reduction of its dose, which is a recurrence of intensified symptoms for which the medicine was started. Due to the muscle relaxant effect, there is a risk of falls and consequent fractures in the elderly. The side effects of nitrazepam depend on the dose of the medicine. They occur mainly at the beginning of treatment and usually disappear during treatment. The risk of side effects is higher in the elderly. If side effects occur, you should inform your doctor, who may decide to change the dose.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Nitrazepam GSK

Keep the medicine out of sight and reach of children. Do not use Nitrazepam GSK after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month. The batch number is abbreviated as Lot. Store below 25°C. Protect from light and moisture. Store in the original packaging. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nitrazepam GSK contains

The active substance of the medicine is nitrazepam. One tablet contains 5 mg of nitrazepam. The other ingredients are: lactose monohydrate, potato starch, talc, magnesium stearate.

What Nitrazepam GSK looks like and contents of the pack

Nitrazepam GSK is a white or almost white tablet in the shape of a convex disc with the marking N on one side and a dividing line. The tablet can be divided into two equal doses. The single pack contains 20 tablets.

Marketing authorization holder

GSK PSC Poland sp. z o.o., ul. Grunwaldzka 189, 60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznań. For more detailed information about this medicine, please contact the local representative of the marketing authorization holder: GSK Services Sp. z o.o., Tel.: +48 22 576 9000

Date of last revision of the leaflet: